[Federal Register Volume 75, Number 192 (Tuesday, October 5, 2010)]
[Notices]
[Pages 61502-61503]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-24906]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0495]
Cooperative Agreement With the Pan American Health Organization
for the Development of an Information Hub for Medical Products and
Related Regulatory Processes and Systems in the Americas Region
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) announces its intention
to accept and consider a single source application to award a
cooperative agreement to the Pan American Health Organization (PAHO)
for the development of an information hub in the areas of medical
products and related regulatory processes and systems (e.g., including
drugs, biologics, vaccines, medical devices, and other medical products
as appropriate) in the region of the Americas.
FOR FURTHER INFORMATION CONTACT:
Management Contact: Katherine C. Bond, Office of International
Programs, Office of the Commissioner, Food and Drug Administration,
White Oak Bldg. 32, rm. 3300, 10903 New Hampshire Ave., Silver Spring,
MD 20993, 301-796-8318, FAX: 301-595-5058, email:
[email protected].
Grants Contact: Kimberly Pendleton, Division of Acquisition and
Grants (HFA-500), Food and Drug Administration, 5630 Fishers Lane, rm.
2104, Rockville, MD 20857, 301-827-9363, FAX: 301-827-7101, email:
[email protected].
For more information on this funding opportunity announcement (FOA)
and to obtain detailed requirements, please contact Kimberly Pendleton.
SUPPLEMENTARY INFORMATION:
I. Funding Opportunity Description
RFA-FD-10-009
Catalog of Federal Domestic Assistance Number(s): 93.103 https://www.cfda.gov
A. Background
FDA announces its intention to accept and consider a single source
application to award a cooperative agreement to the PAHO for the
development of an information hub in the areas of medical products and
related regulatory processes and systems (e.g., including drugs,
biologics, vaccines, medical devices, and other medical products as
appropriate) in the region of the Americas.
B. Research Objectives
The development of an online database (e.g., Web-based) in
English and Spanish for a series of countries providing:
[cir] Overview of the regulated sector including description and
specific data relating to the medical products and related regulatory
processes and systems market;
[cir] Structural overview of the national regulatory process(es)
including information relating to national entities participating in
the regulatory process;
[cir] Data presented by specific regulatory areas (for example,
biologics, vaccines, drugs, medical devices) on processes relating to
product registration, licensing (manufacturer, wholesaler and pharmacy/
vendor), quality control assessment and postmarketing surveillance;
[cir] Data presented on other regulatory areas such as clinical
trials and supply chains;
[cir] Key regulations governing the areas of medical products and
related regulatory processes and systems (e.g., including drugs,
biologics, vaccines, medical devices, and other medical products as
appropriate) per country and/or links to sources where such information
is available.
[cir] Data collected and presented in such a way that ensures
consistency of terminology, consistency in data collection methods, and
robustness, comprehensiveness, and comparability of data.
The establishment of information exchange mechanisms with
the active participation of national regulatory agencies (NRAs) in the
region of the Americas that facilitates the process by which the
information hub and database is populated with information that is
reviewed and maintained in an up-to-date and continual basis.
[cir] A detailed mechanism to maintain and update the hub
information is developed detailing the responsibilities of PAHO and its
Members States in keeping the data and information contained therein
relevant, up-to-date, and comprehensive to encompass the future growth
and complexity in the areas of medical products and related regulatory
processes and systems.
As appropriate, PAHO would work to align or link the
information hub with other ongoing global initiatives of the World
Health Organization (WHO) or its regional offices in regulatory aspects
relating to medical products and related regulatory processes and
systems.
As appropriate, PAHO would work to enable effective
linkage(s) of the information hub with other ongoing initiatives in
regulatory aspects relating to medical products and related regulatory
processes and systems including harmonization efforts, such as the Pan
American Network for Drug Regulatory Harmonization (PANDRH), the ICH
Global Cooperation Group; the Global Health Task Force on Health
Technologies; the Asia-Pacific Economic Cooperation (APEC)
harmonization efforts, and other relevant efforts and initiatives as
appropriate.
The utilization of the data and information contained
within the information hub by NRAs to enable harmonized approaches,
standards and guidelines for regulatory systems. It will support
evidence-based decisionmaking by NRAs and regulated industry sectors,
facilitate the exchange of timely and accurate data, and promote
transparency of regulated approaches and efforts.
[[Page 61503]]
As appropriate, explore with the WHO, the possibility of
expanding this information hub to other WHO Regions.
C. Eligibility Information
The following organizations/institutions are eligible to apply: the
PAHO.
II. Award Information/Funds Available
A. Award Amount
FDA anticipates providing one award of $904,000 (total costs
including indirect costs) in FY 2010 in support of this project.
B. Length of Support
The support will be 1 year with the possibility of an additional 3
years of noncompetitive support. Continuation beyond the first year
will be based on satisfactory performance during the preceding year,
receipt of a non-competing continuation application and available
Federal FY appropriations.
Dated: September 29, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-24906 Filed 10-4-10; 8:45 am]
BILLING CODE 4160-01-S